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Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as add-on Treatment for Early Alzheimer's Disease (ALSTIMAG)

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ClinicalTrials.gov Identifier: NCT01481961
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : March 3, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early Alzheimer's disease (AD).

This study included 15 patients treated with rTMS and whose medication reference is stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected in the MCRR of Besançon and the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96), Rey-complex figure test-copy and Picture naming 80 items test (DO80).

Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A psychometric assessment will be conducted again at the end of treatment week and one month after stopping treatment. A neuropsychometric assessment will be conducted one month after stopping the treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment. Moreover a questionnaire will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and 4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of recent change of the personality (CP6).

The population of this study will be comprised of patients between 60 to 85 years-old with early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be recruited on a voluntary basis, after notification and consent in the research center. This study was conducted over a period of 15 months.


Condition or disease Intervention/treatment
Alzheimer's Disease Cognition Disorders Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study: Cognitive Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)on add-on in Patients With Early Alzheimer's Disease
Study Start Date : November 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: rTMS arm Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)
After locating the left DLPFC, treatment with active rTMS will be directed by 20-minute session during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session). Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during rTMS for any side effects or adverse events.


Outcome Measures

Primary Outcome Measures :
  1. changes in MMSE (Mini Mental State Examination) [ Time Frame: baseline, 1wk, 4wk ]
    The changes in MMSE will constitute the major research outcome measure used to assess response to rTMS.


Secondary Outcome Measures :
  1. changes in HDRS (Hamilton Depression Rating Scale) [ Time Frame: baseline, 1wk, 4wk ]
  2. changes in STAI (State-Trait Anxiety Inventory) [ Time Frame: baseline, 1wk, 4wk ]
  3. changes in BDI (Beck Depression Inventory) [ Time Frame: baseline, 1wk, 4 wk ]
  4. changes in HAMA (Hamilton Anxiety Scale) [ Time Frame: baseline, 1 wk, 4 wk ]
  5. changes in Mattis DRS (Dementia Rating Scale) [ Time Frame: baseline, 1 wk, 4 wk ]
  6. changes in CDR (Clinical Dementia Rate) [ Time Frame: baseline, 1 wk, 4 wk ]
  7. changes in Grober Free and Cued Selective Reminding Test [ Time Frame: baseline, 4 wk ]
  8. changes in TMT (Trail Making Test) [ Time Frame: baseline, 4 wk ]
  9. changes in COT (Crossing Of Test) [ Time Frame: baseline, 4 wk ]
  10. changes in IST (Isaacs Set Test) [ Time Frame: baseline, 4 wk ]
  11. changes in CDT (Clock-Drawing Test) [ Time Frame: baseline, 4 wk ]
  12. changes in Signoret's Battery of Cognitive Efficacy (BEC96) [ Time Frame: baseline, 4 wk ]
  13. changes in Rey-complex figure test-copy [ Time Frame: baseline, 4 wk ]
  14. changes in Picture naming 80 items test (DO80) [ Time Frame: baseline, 4 wk ]
  15. changes in RUD (Resource Utilisation Dementia) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ]
  16. changes in AI (Apathy Inventory) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ]
  17. changes in ADL (Activities of Daily Living) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ]
  18. changes in IADL (Instrumental Activities of Daily Living) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ]
  19. changes in QoL-AD (Quality of Life in Alzheimer's Disease) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ]
  20. changes in CP6 (Questionnaire of recent change in personnality) [ Time Frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
  • subject under treatment by IAChE for at least 3 months.
  • CDR score ≤ 2
  • psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months

Exclusion Criteria:

  • CDR > 2
  • subjects diagnosed with psychiatric disorder (depression according to DSM-IV criteria, bipolar disorder, schizophrenia, addiction)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481961


Locations
France
Psychiatric Department of CHU of Besancon
Besancon, France, 25000
Sponsors and Collaborators
Pierre Vandel, MD PhD
Neurology department of CHU Besancon (Dr Rumbach L, Dr Berger E, Dr Galmiche J)
Memory Center of Research and Resources (MCRR) of Besancon (Dr Magnin E)
Rapid-fr network (Dr Galmiche J)
Clinical Investigation Centre for Innovative Technology Network
Funding by French Internal Project Call for Clinical Research(2010-A00659-30)
Investigators
Principal Investigator: Pierre VANDEL, Prof Psychiatry clinical department - CHU Besançon
More Information

Publications:
Responsible Party: Pierre Vandel, MD PhD, PU PH, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01481961     History of Changes
Other Study ID Numbers: ALSTIMAG
First Posted: November 30, 2011    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015

Keywords provided by Pierre Vandel, MD PhD, Centre Hospitalier Universitaire de Besancon:
Alzheimer's disease
rTMS
cognition

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders